Taro Fujimori

Ultragenyx
Director of Regulatory Affairs CMC
Taro Fujimori is a Director of Regulatory Affairs CMC at Ultragenyx. Taro has worked on the development of therapeutic proteins, fusion proteins, antibodies, imaging antibodies, antibody-drug conjugates, and bispecific antibodies. Taro Fujimori has a BA in Biophysics from the University of Pennsylvania, a PhD in Biophysics from Brandeis University, and Executive MBAs from Columbia Business School and London Business School. He has held post-doctoral positions at the Pennsylvania State University and a joint fellowship at Parke-Davis and the University of Michigan. Taro holds Regulatory Affairs Certifications (RAC) in the following areas: US, EU, and Global.

Related Articles

A Patient-Centric Review of ICH Q6A and ICH6B
Online Exclusives
A Patient-Centric Review of ICH Q6A and ICH6B

The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting guidelines ICH Q6A and Q6B. This provides an excellent opportunity to update ICH Q6A/B to align and work in a complementary manner with the science-, risk/knowledge-based concepts in ICH Q8–Q12. The ISPE Pharmaceutical Quality Lifecycle Implementation (PQLI) Patient-Centric Specification working...